MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ F RM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Customer has indicated that the product is not being returned to zimmer biomet for investigation.Concomitant medical devices: medical product: oxf twin-peg cmntd fem lg pma, catalog: 161470, lot: 216830; medical product: oxf anat brg rt lg size 3 pma, catalog: 159582, lot: 326090.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00037 3002806535-2021-00038.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to stiffness and flexion contracture was performed on (b)(6) 2021.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to stiffness and flexion contracture was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: a2, b4, b5, d8, g3, g6, h1, h2, h6, h10.D11: medical product: biomet bc r 1x40 us, catalog: 110035368, lot: 004bac2504 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00037-1, 3002806535-2021-00038-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.X-rays received: four images were provided with (b)(4) for analysis: one pre-revision anteroposterior (ap) x-ray of both knees (dated (b)(6) 2020); a post-primary fluoroscopy image of the right knee (dated (b)(6) 2020); two ap x-rays dated (b)(6) 2020, one of both knees and another of the right knee only.No mediolateral (ml) x-rays have been received and are required in order to make a full assessment of the component sizing, positioning and alignment.The medial edge of the tibial tray appears to be overhanging the edge of the tibial plateau in the post-primary images.The oxford partial knee surgical technique states that the tibial tray should be flush with (or have less than 2 mm overhang from) the medial edge of the tibial plateau.The complaint description states that the oxford components in the right knee were revised after just over 3 months due to stiffness and flexion contracture.Email communications provided with (b)(4) mention that the surgical technique was used, and that there were no contributing conditions to the adverse event.They also mention that there is no information on whether the device malfunctioned or failed to perform as intended, and that no patient information (e.G.Age, height, weight, activity level) is available.Surgical notes have not been received and therefore patient-related factors such as soft tissue imbalance cannot be discussed.The oxford partial knee surgical technique provides the following guidance: with the bearing in place, manipulate the knee through a full range of motion to demonstrate stability of the joint, security of the bearing and absence of impingement.The thickness of the bearing should be such as to restore the ligaments to their natural tension.The manufacturing history records (mhrs) for the oxford partial knee tibial tray, femoral component and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.It is not possible to determine the root cause of revision without additional information such as surgical notes from both primary and revision surgeries, immediate pre-revision x-rays, ml x-rays, analysis of the revised components, and patient information.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 154776, 1 similar complaint reported with the item 161470 and 1 similar complaint reported with the item 159582.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: -risk management report documents the estimated residual risk associated with the reported event.-the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.-the complaint summery states: it is not possible to determine the root cause of revision without additional information such as surgical notes from both primary and revision surgeries, immediate pre-revision x-rays, ml x-rays, analysis of the revised components, and patient information.-the reported event states revision due to stiffness and flexion contracture.Rom limitation, moderate is documented as a potential harm as an outcome of a number of hazards assessed by the rmf, and is considered a severity 3: moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.-contributed to minor, temporary, or medically reversible injury.-the outcome of this complaint (surgical intervention) is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF UNI TIB TRAY SZ F RM PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11320661
• MDR Text Key: 231588451
• Report Number: 3002806535-2021-00036
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154776
• Device Lot Number: 732530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR